The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:

The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients-A Prospective, Randomized, Multi-center Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906555
• Other study ID #: 08dz1900501-a
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2009
• Last updated: October 12, 2016
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: October 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Adequacy of solute clearance makes a profound impact on clinical outcome in maintenance hemodialysis patients. Thus far, guidelines on the target of solute clearance (Kt/V or URR) are based on patients with three dialysis sessions per week. However, quite a few patients have their dialysis sessions twice per week in China. The dialysis target of solute clearance in this population remains to be elucidated. The aim of this study was to explore the optimum target solute clearance (Kt/V or URR) in maintenance hemodialysis patients with two dialysis sessions per week. Two groups of hemodialysis patients with different Kt/V (1.2 ≤ Kt/V ＜ 1.7 versus Kt/V ≥ 1.7) will be followed until 96 weeks in this prospective, randomized, multi-center, interventional study.

Description:

This is a prospective, randomized, multi-center intervention study. 400 maintenance hemodialysis patients with twice dialysis sessions per week will be enrolled into the study. All the patients have their baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V ＜ 1.7). After treatment intervention, the patients will be randomized to two groups according to their different Kt/V (1.2 ≤ Kt/V ＜ 1.7 vs. Kt/V ≥ 1.7), then the patients will be regularly followed up at baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks and 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing maintenance hemodialysis for more than 12 weeks were included in the study.

2. The patients have their dialysis sessions twice weekly and have baseline Kt/V between 1.2 and 1.7 (1.2 = Kt/V < 1.7).

3. Age from 18 to 80, male or female.

4. Patients have long term vascular access.

Exclusion Criteria:

1. Patients with an expected survival less than 12 months.

2. Without informed consent.

3. Unstable organ disease such as uncurable cancer,active inflammation disease and mental disease.

4. Patients with an expected follow up less than 48 weeks,such as planned kidney transplant.

5. Other conditions regarded as unsuitability by investigator, such as pregnancy, alcohol or drug indulgence. A dry weight more than 90 kg is also excluded in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Renal Replacement Therapy

Intervention

Procedure:
• modification of hemodialysis parameters on dialysis machine
Modification of hemodialysis parameters such as dialysis time, blood flow rate and dialysate flow rate to reach a Kt/V = 1.7.

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao Tong University school of medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcome including mortality and morbidity		2 years	Yes
Secondary	complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality		2 years	Yes